Medical device patents

Medical device patents
Medical device patents

Why are medical device patents important? New medical devices are both expensive and risky to produce. Without patent protection, few new medical devices would ever reach the market.

The number of filed and granted medical device patents has substantially increased over the last few years, with certain US states (California, Minnesota and Massachusetts) leading the way.  Certain countries, in particular Japan and Germany, are also heavily active in this area.

Write carefully: In contrast to some high tech areas, such as computers and software, which often rely on a larger number of lower impact patents, the medical device industry tends to rely on a smaller number of higher impact patents.  What this means is that any given medical device patent is more likely than average to be subjected to a high level of competitor scrutiny.  Remember also that in the medical device field, both the patent office and the courts may view the “person having ordinary skill in the art” (PHOSITA) as being highly skilled, such as a PhD or MD. Thus care should be given to write accordingly. It is helpful to include a lot of detail and discuss alternative approaches. Research and disclose prior art, and of course try to write claims in a manner that distinguishes over prior art.

Remember Europe: Medical devices are an international market, and often due to slower FDA review times, US firms first introduce new products in Europe.  Many US medical device patent applications end up being filed in Europe.  Thus European patent rules are often important.

Although there are a few glaring exceptions, US medical device patent eligibility rules generally tend to be expansive. The USPTO typically reviews these patents in its 3700’s art unit.  In recent years, this art unit has continued to grant medical device patents according to its historical percentages.

European patent eligibility rules are also generally quite permissive with regard to “gadgets” and in-vitro devices, as well as technical aspects of in-vivo devices.  However Europe (See G-II 4.2.1) doesn’t allow “methods of treatment of the [living] human or animal body by surgery or therapy and diagnostic methods practiced on [usually interpreted as “in”] the human or animal body “.  Fortunately the Europeans tend to read this exclusion narrowly, so this isn’t actually quite as restrictive as it sounds. However from a claim writing perspective, be careful of method claims with limitations that read on the patient’s body.  Try to focus more on the details of how the gadget (device) itself works.  Watch out for methods that remove a tissue, treat it, and then return it to the body, as these could run into trouble.

International patents

World map by Japinderum (CC BY-SA 3.0) license
PCT international patent treaty countries

Applying for international patents: Most countries maintain their own separate patent and trademark offices, and typically (Europe being a partial exception), patents operate within national borders.  Thus a US patent, for example, covers just the US.

The Paris Convention: The process of extending a patent application to cover multiple countries was worked out by several international treaties. One important treaty, which is still in effect, was the 1880’s era Paris Convention. This established that, for example, a foreign patent office will recognize the priority of a US utility patent application (or provisional patent application) for up to 12 months after its initial filing date.

This was a good start, but it often takes more than 12 months to determine if a new invention is commercially important. It is very expensive to file patent applications in many different countries. So for many applicants, 12 months just wasn’t long enough.

The Patent Cooperation Treaty: To extend this time, in the 1970’s the Patent Cooperation Treaty (PCT) was enacted. This treaty is a bit complicated. Think of it as a temporary “holding tank” for patent applications. The key idea is that if you file a PCT application within 12 months of the filing date of the original patent application, you can extend your ability to then file international patents to 30 months from the filing date of the original patent application.

After 30 months from the filing date of the original patent application, however, you then need to make some tough decisions. It typically costs thousands of dollars to file (i.e. enter the national phase) in each separate country. So unless the invention is really very promising, often applicants either continue on only in the US, or else only file nationally in a few select countries.

The Patent Prosecution Highway: Typically, each local (national) patent office will then want to examine the patent application itself. This is both expensive and duplicative of resources. To help streamline the process, in the late 2000’s, various Patent Prosecution Highway (PPH) agreements were initiated, typically on a bilateral (country-to country) basis. Here, if a patent application has claims allowed by one (PPH) country’s patent office, the applicant can petition to have these claims accepted by other participating PPH offices. The US participates in the PPH, as do a number of other countries. The PPH is great when it works, but it is presently a patchwork of agreements rather than a comprehensive international treaty. So view the PPH as being somewhat in the “pilot” or “beta” stage.

Patent non-publication requests

lock
Keeping confidential

Non-publication requests: Patent non-publication requests can be an important part of your IP strategy. Under US law, patent applications can be filed with patent non-publication requests. When this request is made, the USPTO will hold a patent application secret (i.e. will not publish it) until when and if the patent finally issues. Otherwise, absent this request, the patent office will automatically publish the patent application 18 months after the initial filing date.

When to consider filing a non-publication request: Non-publication requests are particularly appropriate for certain types of software patent applications, such as “business methods” and related software patents. This is because the US patent law for this type of software is presently in an unsettled state, and the international acceptance of this type of patent is also more limited. By filing with a non-publication request, your disclosure remains a trade secret. If the USPTO grants you a patent that is broad enough to be worth disclosing your work; great. If not, then you can continue to elect to keep your work hidden from the public.

When filing a non-publication request may not be appropriate: If you have plans to file outside the US, then by international treaty, you must file for international patents within 12 months of your initial filing date, and also allow your initial application to be published within 18 months. Here you can either not include a non-publication request on initial filing, or alternatively send in another form rescinding your non-publication request.

Other considerations: Unless a specific reason for non-publication can be identified, I generally recommend filing using the default, “publication” mode. This is because published patent applications can be useful. They help provide published prior art to help establish priority over patent filings from competitors. Additionally, published patent applications look impressive to investors, and can help give you more credibility.

Software patents in China, Europe, and the US

China-Europe-US
Software patents in China, Europe, and the US

Summary: In general, software patents that deal with technical effects, physical parameters, and improving computer function tend to be favored. By contrast, software patents focused on business methods tend to be disfavored.

China: Before April 2017, China restricted software patents to methods that solve technical problems, control internal or external processes according to the laws of nature, and produce technical effects in accordance with the laws of nature.  Machine readable medium type claims, and game patents, were not allowed. However these guidelines are now somewhat more expansive. For example, business methods that also have a technical aspect may now also be eligible for patent protection.

Europe: Software patents should have a “technical effect” (e.g. controlling industrial aspects, improvements in computer technology, data pertains to physical properties,). Pure methods directed “only” to doing business and computer programs without “technical effect” are not allowed.

United States: The rules are presently incoherent. Traditionally (before 2014-2015) US policy was permissive. Indeed the present written (i.e. statutory) US legal standard is that all types of software patents are permitted. However the latest judicial rulings and USPTO policies are that at least some software patents may represent “abstract ideas” run on “generic computers” that are not patentable unless there is “something more”. Unfortunately the terms “abstract”, “generic computer” and “something more” are effectively undefined (and thus can vary according to the whims of the judge or patent examiner at hand).

How will US software patent rules evolve in the future? This is a bit like reading tea leaves, but the latest US software patent decisions appear to be trending more towards a Chinese or European-like approach. On average, “Business method” software is increasingly being rejected as being “abstract”. However software that exhibits technical effects, operates on data pertaining to physical properties, or improves computer function is often accepted on the basis that it is not “abstract”, not run on “generic computers” or contains “something more”.  Arguably the US, presently lacking coherent rules, may be at least temporarily filling the void by borrowing rules from other countries.  The constitutionality of this approach remains to be determined.

About Silicon Valley and the San Francisco Bay Area

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Golden Gate Bridge, San Francisco

Silicon Valley and the San Francisco Bay Area have a worldwide reputation for innovation. But is there any subjective evidence for this? What do the patent statistics say?

According to the USPTO statistics, at http://www.uspto.gov/web/offices/ac/ido/oeip/taf/cls_cbsa/allcbsa_gd.htm, as of 2013, Silicon Valley “classic”, characterized as San Jose, Sunnyvale, and Santa Clara (Metropolitan Statistical Area 141940), led the field in patents with 12,899 patents granted. By contrast, the remainder of the San Francisco Bay Area minus Silicon Valley, characterized as San Francisco, Oakland, and Fremont (Metropolitan Statistical Area 141860) came in a respectable second at 8,721 patents.

Here the San Jose, Sunnyvale, and Santa Clara area includes other cities such as Campbell, Cupertino, Los Altos, Los Gatos, Milpitas, Monte Sereno, Morgan Hill, Mountain View, Palo Alto, San Jose, Santa Clara, Saratoga, and Sunnyvale.

By contrast, the San Francisco, Oakland, and Fremont area includes other cities such as Belmont, Burlingame, Emeryville, Foster City, Fremont, Menlo Park, Millbrae, Newark, Oakland, Redwood City, San Bruno, San Carlos, San Francisco, San Mateo, South San Francisco, and Union City.

Combining the two, the San Francisco Bay Area as a whole dominates the rest of the country, at an impressive 21,620 patents granted in 2013. By contrast, the next runner-up, the New York-New Jersey area, comes in at 7,886 patents. The Los Angeles area is close behind at 6,271 patents, followed by the Boston area at 5,610 patents. So from a patent perspective, yes the San Francisco Bay area is, in fact, pretty unique.